Direct Acting Antiviral-Post Authorization Safety Study
- Conditions
- Hepatocellular CarcinomaHepatitis C
- Registration Number
- NCT03707080
- Lead Sponsor
- Target PharmaSolutions, Inc.
- Brief Summary
This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Current participant in TARGET-HCC
- Adults, age ≥18 years
- First diagnosis of HCC (mixed HCC/cholangiocarcinoma may be included). Diagnosis may be histological/cytological and/or radiological.
- BCLC Stage A
- Underwent, undergoing, or planned to undergo therapy for HCC, with exception that transplant as prior or planned treatment for HCC is excluded.
- HCV RNA positive
Screening
- Inability to provide informed consent
- HCC-free imaging (as defined in Section 9.1.1) after treatment of initial HCC prior to Screening (see Section 9.2.9 for imaging details)
- Prior liver transplantation
- Hepatitis B Virus (HBV) surface antigen positive (HBsAg)
- Previously treated with direct-acting antiviral agents (not DAA-naïve); Note that prior (peg)IFN and/or ribavirin therapy is allowed
Enrollment Inclusion Criteria:
- Continued participation in TARGET-HCC
- No recurrence or progression of initial HCC beyond BCLC Stage A prior to Enrollment/Baseline
- HCC-free imaging (as defined in Section 9.1.1) at Enrollment/Baseline (see Section 9.2.9 for imaging details; participants may remain in Screening until an HCC-free image is obtained)
- Remains DAA-naïve (prior therapy with (peg)IFN and/or ribavirin is allowed)
Enrollment Exclusion Criteria:
- Liver transplantation since Screening
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to HCC recurrence - Prospective Cohort up to 24 months Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.
- Secondary Outcome Measures
Name Time Method Number of events of early HCC recurrence - Prospective Cohort up to 24 months Number of events (early HCC recurrence) associated with DAA therapy relative to no DAA therapy in the prospective cohort.
Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort up to 24 months Number of events (early HCC recurrence) associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort.
historical cohort of HCV patients not exposed to DAA with initial HCC diagnosis and subsequent successful treatment of HCC.Time to HCC recurrence - Prospective Cohort relative to Historical Cohort up to 24 months Time to HCC recurrence associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort.
Related Research Topics
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Trial Locations
- Locations (61)
Clinical Research Institute@ Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Rutgers-Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Stanford University
🇺🇸Palo Alto, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of California - Davis Clinical Trials
🇺🇸Sacramento, California, United States
University of Florida Hepatology Research at CTRB
🇺🇸Gainesville, Florida, United States
Hospital Universitario Politècnic La Fe
🇪🇸Valencia, Spain
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Northwestern University Division of Gastroenterology and Hepatology
🇺🇸Chicago, Illinois, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States
Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Southern Therapy and Advanced Research LLC
🇺🇸Jackson, Mississippi, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
IRCCS "Casa Sollievo della Sofferenza"
🇮🇹San Giovanni Rotondo, Italy
Hôpitaux Universitaires Paris Centre
🇫🇷Paris, France
Weill Cornell Medical College
🇺🇸New York, New York, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Carolinas HealthCare System Center for Liver Disease
🇺🇸Charlotte, North Carolina, United States
Humanitas Mirasole IRCCS
🇮🇹Rozzano, Italy
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Wenatchee Valley Hospital & Clinics
🇺🇸Wenatchee, Washington, United States
A.O.U.P. di Palermo
🇮🇹Palermo, Italy
Hospital Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
CHU de Nice - Hôpital L'Archet 2
🇫🇷Nice, France
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Providence Health & Services Cancer Clinical Trials
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Vanderbilt University Medical Center - GI Research Office
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Northwell Health - Center for Liver Disease
🇺🇸Manhasset, New York, United States
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Bon Secours Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
Baylor Scott & White All Saints
🇺🇸Fort Worth, Texas, United States
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
New York University Langone Health
🇺🇸New York, New York, United States
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
University of Virginia Transplant Center
🇺🇸Charlottesville, Virginia, United States
University of Florida - Health Gastroenerology
🇺🇸Jacksonville, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States